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Treatment With SU11248 in Patients With Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT00056693
Recruitment Status : Completed
First Posted : March 24, 2003
Last Update Posted : July 21, 2008
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Sunitinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor
Study Start Date : April 2003
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: Sunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity
Other Name: Sutent, SU011248


Outcome Measures
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Primary Outcome Measures :
  1. Radiographic objective disease response [ Time Frame: From screening until disease progression or discontinuation of study ]

Secondary Outcome Measures :
  1. To assess safety (adverse events and lab abnormalities) [ Time Frame: From screening until patient death or discontinuation of study ]
  2. To assess patient-reported outcomes and treatment-related symptoms [ Time Frame: From screening until patient death or discontinuation of study ]
  3. To assess pharmacokinetics and biomarkers [ Time Frame: From screening until patient death or discontinuation of study ]
  4. To assess overall survival at 1 year [ Time Frame: From screening until patient death or discontinuation of study ]
  5. To assess other measures of antitumor efficacy including TTP and survival [ Time Frame: From screening until patient death or discontinuation of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of carcinoid tumor or pancreatic islet cell tumor.
  • Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell carcinoma, or any other second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
  • Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056693


Locations
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United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90033-0800
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
San Francisco, California, United States, 94115-1705
United States, Illinois
Pfizer Investigational Site
Pinckneyville, Illinois, United States, 62274
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Missouri
Pfizer Investigational Site
St Louis, Missouri, United States, 63110
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00056693     History of Changes
Other Study ID Numbers: RTKC-0511-015
First Posted: March 24, 2003    Key Record Dates
Last Update Posted: July 21, 2008
Last Verified: July 2008
Keywords provided by Pfizer:
Neuroendocrine tumor, advanced disease, sunitinib, Phase 2
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Sunitinib
Antineoplastic Agents
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action